US health regulators make it easier to approve new eye tissue storage solutions

US health regulators are reclassifying corneal storage mediums with preservatives, including antifungals, into a less restrictive category. This means new products in this area will face fewer regulatory hurdles to reach patients.

For decades, medical devices have been categorized into classes that determine how much testing and review they need before they can be sold. Moving a device from a higher class to a lower one reduces the time and cost for manufacturers to bring new products to market. This change could speed up the availability of new ways to store donor corneas, potentially improving outcomes for people needing eye transplants.